GUEST COLUMNISTS

• An Analysis Of MHRA’s Latest Annual GMP Inspection Deficiencies Report

  The U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) recently published its GMP deficiencies data for drug product issued during inspections in 2019. This article provides a high-level overview of that data, including trends from the four most recent MHRA reports (2015, 2016, 2018, and 2019), and identifies and evaluates the critical and major deficiencies from 2019. 

• An Introduction to Polymeric Materials for Medical Devices

  What's the best utility of polymeric materials employed in healthcare and medical devices? Eric George, Ph.D., of ERG Polymers LLC discusses terminology and nomenclature, polymer structure and chemistry, and a process for material selection for specific applications, focusing on thermoplastics. And stay tuned for future follow-up articles that do a deep dive on polymers for coronary angioplasty, point-of-care testing and wearables, ophthalmic applications, and drug delivery!

• Introduction To ASTM E3263-20 On Qualification Of Visual Inspection For Residues

  The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.

• 6 Things We Need From FDA Before Full 2023 DSCSA Enforcement

  This article suggests concrete actions the FDA can take to help unify a complex and diverse group of stakeholders prior to enforcing the full requirements of the Drug Supply Chain Security Act (DSCSA) in Nov. 2023.

• Risk-Based Postmarket Surveillance (PMS) In The Age Of EU MDR: Risk-Based Trending

  Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. Jayet Moon concludes his four-part article series on risk-based postmarket surveillance in the age of EU MDR by examining the salient features of a sound risk-based trending process and methodology and discussing what to look for in a trend analysis.

• Continuity Is The Key To Success For Your Medical Device Company

  When your company focuses on improving its bottom line, two common methods are to reduce the size of the workforce or to divest from direct manufacturing responsibility. Also, gone are the days when an employee stays with a company until they retire. As a result of these factors, many medical device companies are losing valuable experience. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, discusses what a company can do to address this knowledge drain.

• Facility Design & Construction Tips For Up-Start Biotech Companies

  Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.

• Seeing Double: Using Digital Twins To Improve Pharma Processes

  The pairing of the virtual and physical worlds not only enables systems to be adapted or repaired from afar, but the approach also further enables the analysis of data and monitoring of systems to avoid problems before they even occur.